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A Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

A Multicenter, Prospective, Non-interventional, Observational Study to Evaluate the Efficacy and Safety of Dapagliflozin in Patient With Type 2 Diabetes Mellitus and Hypertension

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05970237
Enrollment
9000
Registered
2023-08-01
Start date
2023-07-26
Completion date
2025-10-21
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hypertension

Brief summary

The purpose of this clinical trial is to evaluate the efficacy and safety of dapagliflozin in patient with type 2 diabetes mellitus and hypertension

Interventions

None listed

Sponsors

Boryung Pharmaceutical Co., Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Those diagnosed with type 2 diabetes mellitus accompanied by hypertension who are scheduled to be administrated Trudapa Tab. or Trudapa M SR Tab. * Those who voluntarily signed a written personal information agreement to participate in this clinical study. * Those able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion.

Exclusion criteria

* Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.) * Those who have a history of taking dapagliflozin within 4 weeks of baseline (Visit 1) * Those who are expected to need insulin prescription during the study period * Pregnant women, breast-feeding women

Design outcomes

Primary

MeasureTime frame
Target blood pressure control rate12weeks after administration
Target blood glucose achievement rate12weeks after administration

Countries

South Korea

Contacts

Primary ContactShinyoung Oh
syoh@boryung.co.kr+82-2-708-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026